510(k) K022115 ยท DTZ Oxygenator, Cardiopulmonary Bypass
CAPIOX RX05 HOLLOW FIBER OXYGENATOR W/WITHOUT HARDSHELL RESERVOIR
| Applicant | Terumo Corp., Elkton MD, US |
| Decision | Substantially Equivalent, Sep 27, 2002 |
| Received | Jul 1, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K022115
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.